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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01590719




Registration number
NCT01590719
Ethics application status
Date submitted
2/05/2012
Date registered
3/05/2012
Date last updated
9/08/2016

Titles & IDs
Public title
A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer
Scientific title
A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Onartuzumab (MetMAb) In Combination With 5-Fluorouracil, Folinic Acid, And Oxaliplatin (mFOLFOX6) In Patients With Metastatic HER2-Negative Gastroesophageal Cancer
Secondary ID [1] 0 0
2012-000858-57
Secondary ID [2] 0 0
YO28252
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Onartuzumab (MetMAb)
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Folinic acid
Treatment: Drugs - Levofolinic acid
Treatment: Drugs - 5-Fluorouracil

Experimental: Onartuzumab (MetMAb) with mFOLFOX6 - Onartuzumab (MetMAb) in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin)

Placebo Comparator: Placebo with mFOLFOX6 - Placebo in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin)


Treatment: Drugs: Placebo
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

Treatment: Drugs: Onartuzumab (MetMAb)
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

Treatment: Drugs: Oxaliplatin
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

Treatment: Drugs: Folinic acid
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

Treatment: Drugs: Levofolinic acid
If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

Treatment: Drugs: 5-Fluorouracil
5-Fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) in all patients
Timepoint [1] 0 0
Up to 18 months
Primary outcome [2] 0 0
Progression-free survival (PFS) in patients with Met-positive tumors
Timepoint [2] 0 0
Up to 18 months
Secondary outcome [1] 0 0
Safety: incidence of adverse events
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Overall response rate (ORR)
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Duration of response (DOR)
Timepoint [4] 0 0
18 months

Eligibility
Key inclusion criteria
- Adult patients, 18 years of age and older

- Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic
disease, not amenable for curative therapy

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Life expectancy >3 months

- Presence of tissue sample for immunohistochemistry assay of Met receptor and HER2
status (if unknown)

- Radiographic evidence of disease; measurable disease or non-measurable but evaluable
disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
Patients with peritoneal disease would generally be regarded as having evaluable
disease and allowed to enter the trial.

- For women who are not postmenopausal or surgically sterile; agreement to use an
adequate method of contraception (e.g., hormonal implant) during the treatment period
and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after
the last dose of oxaliplatin

- For men: agreement to use a barrier method of contraception during the treatment
period and for 90 days after the last dose of onartuzumab/placebo and 6 months after
the last dose of oxaliplatin

- Adequate laboratory values
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- HER2-positive tumor (primary tumor or metastasis)

- Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant
or neoadjuvant chemotherapy must be completed at least 6 months prior to
randomization)

- Prior treatment with investigational drugs that target the hepatocyte growth factor
(HGF) or Met pathway

- History of other malignancy within the previous 5 years, except for appropriately
treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin
carcinoma, Stage 1 uterine cancer, and localized prostate cancer

- Receipt of an investigational drug within 28 days prior to study start

- Clinically significant gastrointestinal abnormalities, except from gastric cancer
(e.g., Crohn's disease)

- Significant history of cardiac disease

- Significant vascular disease

- Infection with human immunodeficiency virus, hepatitis B, or hepatitis C

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
123
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Woodville South
Recruitment hospital [4] 0 0
- East Bentleigh
Recruitment hospital [5] 0 0
- Heidelberg
Recruitment hospital [6] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
VIC 3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore
Country [13] 0 0
Taiwan
State/province [13] 0 0
Tainan
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taipei
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taoyuan County
Country [16] 0 0
Thailand
State/province [16] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, multicenter, double-blind, placebo-controlled study will evaluate the
efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with
metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients
will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in
combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo
until disease progression, unacceptable toxicity, patient or physician decision to
discontinue treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01590719
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01590719